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DCVAC

Extended indication Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Therapeutic value No judgement
Registration phase Clinical trials

Product

Active substance DCVAC
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Prostate cancer
Extended indication Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Manufacturer Sotio
Mechanism of action Immunostimulation
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Immunostimulants

Registration

Registration route Centralised (EMA)
Submission date 2020
Expected Registration 2021
Orphan drug No
Registration phase Clinical trials
Additional remarks Dit geneesmiddel is geclassificeerd als een ATMP.

Therapeutic value

Therapeutic value No judgement
References NCT02111577

Expected patient volume per year

References NKR; GIPdatabank
Additional remarks 2.302 diagnoses prostaatkanker stadium 4 in 2015. 75% van deze patiënten ontwikkelt CRCP (n=1.727). In 2015 werden 1.648 patiënten voor deze indicatie behandeld met enzalutamide. Een deel van deze patienten zal in aanmerking komen voor deze behandeling.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions prostate cancer at various stages
References https://www.sotio.com/pipeline/dcvac-product-candidates

Other information

There is currently no futher information available.